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Pediatric Development: Can Increasing Collaboration Lead to Fewer Unnecessary Trials?
Session Chair(s)
Max Wegner, PHARMD, RPH
Senior Vice President,Head Regulatory Affairs, Bayer, Germany
An evolving regulatory framework supports and incentivizes pediatric drug development. This session compares recent experience in the US, EU, China, and Canada and explores options for advancing global approaches.
Learning Objective : Discuss the evolving global regulatory framework for development of pediatric medicines in the US, EU, China, and Canada; Describe common challenges and opportunities faced with global planning and conduct of pediatric programs; Review case studies illustrating a global approach for development of pediatric medicines.
Speaker(s)
Health Canada Perspectives
Director, Strategic and Horizontal Policy, Health Canada, Canada
Can Increasing Collaboration Lead to Fewer Unnecessary Clinical Trials? FDA Perspectives
Director, Division of Pediatric and Maternal Health, Office of New Drugs, CDER, FDA, United States
Considerations on Promoting Pediatric Clinical Trials in China: Perspective from Agency
Deputy Director, Center for Drug Evaluation, National Medical Products Administration (NMPA), China
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